This course covers the key aspects of IND requirements which are relevant for an IND study in European sites.
Who it is suitable for:
Those involved in conducting clinical trials in Europe under FDA regulations, for example, Project Managers, CRAs, CTAs, investigators, study nurses.
Overview of FDA and it's departments
Overview of Code of Federal Regulations Title 21
Relevant regulations for Clinical Research
FDA Guidelines relating to Clinical Research
When and how CFR applies in Europe
Key differences between US and EU requirements